BOWIE-DICK MINI PAK, MODEL BD 115

K024293 · Steritec Products, Inc. · JOJ · Aug 11, 2003 · General Hospital

Device Facts

• Record ID: K024293
• Device Name: BOWIE-DICK MINI PAK, MODEL BD 115
• Applicant: Steritec Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Aug 11, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

Device Story

SteriTec Bowie-Dick Mini Pak (Model BD 115) is a chemical sterilization process indicator; used in pre-vacuum steam sterilizers. Device detects residual air by monitoring sterilization conditions (132° C for 3.5 minutes). Principle of operation: chemical indicator undergoes color change from purple to green upon exposure to proper steam sterilization conditions. Non-uniform color change indicates presence of air (2° C or greater temperature difference). Used by healthcare personnel in clinical settings to verify sterilizer performance. Provides visual confirmation of sterilization efficacy; aids in quality control of steam sterilization cycles.

Clinical Evidence

Bench testing only.

Technological Characteristics

Chemical sterilization process indicator; color-changing reagent (purple to green); designed for 132° C, 3.5-minute pre-vacuum steam sterilization cycles; passive indicator device.

Indications for Use

Indicated for use in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes to detect residual air.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2003

Ms. Linda Nelson Regulatory Affairs Manager SteriTec Products, Incorporated 599 Topeka Way, Suite 700 Castle Rock, Colorado 80109

Re: K024293

Trade/Device Name: SteriTec Bowie-Dick Mini Pak, Model No BD 115 Regulation Number: 880.2800 Regulation Name: Sterilization Process indicator Regulatory Class: II Product Code: JOJ Dated: June 18, 2003 Received: June 19, 2003

Dear Ms. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 -Ms. Nelson

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Burrer
S. Susan Burrer, DDS

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

1224243 510(k) Number (if known):

Device Name: SteriTec Bowie-Dick Mini Pak, Model No. BD 115

## Indications For Use:

SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

Qim S. Win

(Division Sign-Off) Division of Anesthesiology. General Hospital. Infection Control. Denta

510(k) Number: K024293

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Concurrence of CDRH, Office of Device Evaluation (ODE)